Roche Molecular Systems, Inc. v. Cepheid

Docket No. 2017-1690

October 9, 2018

Brief summary: DC grant of SJ of invalidity of Roche’s diagnostic method and primer claims under § 101 affirmed (“[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry”).

Summary: Roche appealed DC grant of SJ of invalidity of its US 5,643,723 “directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis” (“MTB”) under § 101. The ‘723 patent relates and claims a polymerase chain reaction (PCR)-based test for detecting “eleven MTB-specific signature nucleotides” in the MTB rpoB gene from a “biological sample” and thereby identifying “whether or not a biological sample contains MTB…and…if MTB is present, predict whether that MTB is a strain that is resistant to rifampin treatment.” Claims 17-20 are directed to primers “having 14-50 nucleotides that hybridize” to an MTB rpoB gene “comprising at least one position-specific” MTB “signature nucleotide” (claim 20 being directed to the “full DNA sequences of certain primers”). Roche brought an infringement suit against Cepheid with respect to Cepheid’s “Xpert® MTB/RIF Assay” for detecting rifampin-resistant MTB, and Cepheid successfully argued that the asserted claims are invalid under § 101. The FC panel reviewed the DC’s grant of SJ under the law of the Ninth Circuit and the § 101 question de novo (Voter Verified, FC 2018). The FC panel considered the § 101 question under the two-step Alice framework which asks: 1) are the claims “directed to” a patent-ineligible concept? and 2) do the claims “contain[] an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-eligible application” (Alice, US 2014; Mayo, US 2012; Enfish, FC 2016; CellzDirect, FC 2016; Ariosa, FC 2015; Genetic Techs., FC 2016; In re BRCA1, FC 2014). Roche argued the primer claims are “directed to artificial, man-made primers that are different from naturally occurring DNA” in having “both a 3-prime end and a 3-prime hydroxyl group”, but the FC panel found that “BRCA1 forecloses Roche’s arguments” (“DNA structure with a function similar to that found in nature can only be patentable as a composition of matter if it has a unique structure, different from anything found in nature” and “[p]rimers do not have such a different structure”; e.g., “a primer having an identical sequence to naturally occurring DNA without further modification is a natural phenomena” and “[t]he eleven position-specific signature nucleotides…are naturally occurring”). The FC panel acknowledged that “Roche’s discover[ies]….are valuable contributions to science and medicine” but explained that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry” (Myriad, US 2013; Ariosa, FC 2015; “being the first to discover a previously unknown naturally occurring phenomena or a law of nature alone is not enough to confer patent eligibility” (Mayo)). The FC panel also concluded that claim 1’s “detecting step…is a mental determination step” and “establishes that the method claims are directed to a relationship between the eleven naturally occurring position-specific signature nucleotides and the presence of MTB in a sample”, “a natural phenomenon, which itself is ineligible for patenting”. The FC panel held “that the method claims do not contain an inventive concept that transforms the eleven position-specific signature nucleotides…into patent-eligible subject matter” since, e.g., “PCR amplification and detection were ‘routine’ when the patent application was filed” and “[i]t is a well-established law of nature that ‘complementary nucleotide sequences bind to each other”. The FC panel likened this case to BRCA1 and differentiated it from CellzDirect in which the invention “created an entirely new laboratory technique that ‘is not simply an observation or detection’”. The FC panel therefore affirmed the DC’s grant of SJ. Judge O’Malley concurred but believes the court “should revisit [its] holding in BRCA1 at least with respect to the primer claims” as only the question of whether the DC abused its discretion” in finding the accused infringer raised a substantial question regarding invalidity under § 101.”

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